Nutritional StatusNUTRIHEALTHNCT03284840
Adults Nutrition as a Protective or Health-risk Factor
An observational study of Nutritional Status and Nutrient Deficiency, run by Institute of Nutrition, Slovenia (Nutris) at 3 sites in Slovenia.
Trial summary
To obtain up-to-date data on nutrient intakes in adults, a national dietary survey - the EU Menu study will be conducted during 12 consecutive months in 2017/2018, providing data on the consumption of foods and enabling the assessment of energy and macronutrient intakes. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency
- What is being tested?
- Assessement of nutritional status and Thyroid size
- How many people
- 280 participants
- Where
- 3 sitesSlovenia
- Study dates
- 1 Jun 2017to 31 Dec 2018
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This observational study is conducted on randomly selected residents of Republic of Slovenia. The EU Menu study (LOT2) include a minimum of 1.133 of habitants from Slovenia in the age 18-74 years. In line with the EU Menu methodology and to ensure representativeness of the sample, participants will be randomly selected from the Slovenian population using Central Population Register (selection outsourced by the Statistical Office of Republic of Slovenia ), and visited on their home. After completion of the EU Menu Survey (questionnaires on self-reported health status and food intake), participants will be invited to collaborate in the proposed study.
Who may be able to join
- Resident of Republic of Slovenia (included to the register of residents)
- Finished EU MENU Slovenia Study
Who cannot join
- Not willing to give blood\&urine sample
- Long-term disease
- Living in institutions with controled diet, such as such as in elderly care, hospital, prison, etc.
Trial locations and contacts
3 sites in 1 country.
Slovenia3 sites
National Institute of Public Health, Slovenia
Ljubljana, 1000
Nutrition Institute, Ljubljana
Ljubljana, 1000
University Medical Centre Ljubljana
Ljubljana, 1000
About this study
Official title: NUTRIHEALTH - Adults Nutrition as a Protective or Health-risk Factor
To obtain up-to-date data on nutrient intakes in adults, a national dietary survey - the EU Menu study will be conducted during 12 consecutive months in 2017/2018, providing data on the consumption of foods and enabling the assessment of energy and macronutrient intakes. Participating subjects will be invited to NUTRIHEALTH study for assessment for micronutrient status (focusing into vitamin D, folic acid, vitamin B12, and iron) and medical examination, in which thyroid size will be aslo measured, to investigated thyroid epidemiology in Slovenia.
- Conditions
- Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency, Vitamin D Deficiency, Vitamin B 12 Deficiency, Folic Acid Deficiency
- Being tested
- Assessement of nutritional status, Thyroid size
- Keywords
- dietary intake, nutritional status, micronutrients, thyroid health
- Medical subject headings
- Vitamin D Deficiency, Vitamin B 12 Deficiency, Folic Acid Deficiency, Anemia, Iron-Deficiency, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessement of nutritional statusDiagnostic test
Nutritional status for vitamin D, folic acid, vitamin B12 and iron.
Thyroid sizeDiagnostic test
Thyroid size by ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Adults (18-65 years) | Not described Receives: Diagnostic Test: Assessement of nutritional status; Diagnostic Test: Thyroid size | |
| Elderly (65-74 years) | Not described Receives: Diagnostic Test: Assessement of nutritional status; Diagnostic Test: Thyroid size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of inadequate vitamin D status
epidemiology of vitamin D status will be investigated
Measured: 1 year
Assessment of thyroid health
epidemiology of thyroid Health will be investigated
Measured: 1 year
Secondary outcomes (3)
Assessment of inadequate vitamin B12 status
epidemiology of vitamin 12 status will be investigated
Measured: 1 years
Assessment of inadequate folic acid status
epidemiology of folic acid status will be investigated
Measured: 1 years
Assessment of inadequate iron status
epidemiology of iron status will be investigated
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start1 Jun 2017
- Primary completion13 Sep 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Public Health, Slovenia, University Medical Centre Ljubljana
- Responsible party
- Sponsor
- Investigators
- Igor Pravst, PhD, Study chair, Nutrition Institute, Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284840
- Sponsor's protocol ID
- KME72/07/16
- Acronym
- NUTRIHEALTH
- Status last verified
- Feb 2020
- First submitted
- 13 Sep 2017
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zaletel K, Tuta K, Usaj T, Studen KB, Bajuk NB, Jesenko M, Radevska T, Pirnat E, Gregoric M, Blaznik U, Hribar M, Pravst I, Gaberscek S. Occurrence of clinically relevant thyroid nodules in adults. Radiol Oncol. 2026 Jan 13;60(1):97-105. doi: 10.2478/raon-2026-0001. eCollection 2026 Mar 1.
PubMed 41527959